Programme 2020

December 14-15, 2020 | All times in CT

8:00 AM - 8:45 AM

Registration

8:45 AM - 8:50 AM

Chair’s Opening Remarks

8:50 AM - 9:25 AM - Keynote

Small Molecules

Bespoke Dosing for Pediatric Patients

Rick Panicucci, Senior Vice President CMC, QED Therapeutics

  • Current clinical manufacturing utilize a “one size fits all” approach
  • For very young patients this is far from ideal
  • Personalized dosing based on weight of subject
  • One patient per batch

9:30 AM - 10:05 AM - Case Studies

Small Molecules

In-Silico Excipient Screening for Pharmaceutical Formulations

Gabriele Sadowski, Professor for Thermodynamics, TU Dortmund University

  • Reliable excipient selection based on thermodynamic modeling
  • Predicting long-term stability and influence of humidity  
  • Amorphous solid dispersions
  • Lipid-based formulations
  • Self-amorphous systems

Device Development

10:10 AM - 10:45 AM - Solution Spotlights

Small Molecules

The Role of Biopharmaceutics in Early Drug Development

Chris Roe, Senior Research Fellow , Quotient Sciences

Nominated candidates entering clinical development often have sub-optimal physicochemical, biopharmaceutic or DMPK properties for oral delivery. Development teams are challenged with how to understand the properties of new drug candidates, how to design the appropriate formulation strategy and how to move quickly and successfully into early phase clinical trials. Along the way, it is important to identify developability risks and take steps to mitigate these factors, balanced carefully against time and cost investments.

This webinar discusses effective strategies being used by biotech and pharmaceutical companies to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline; and explores alternative approaches for accelerating your early development plan.

Learn about case studies relating to:

• Poor solubility molecules
• Drugs with short half-lives
• Preclinical to clinical translation

Device Development

Considerations in Primary Packaging Component Selection for Parenteral Drug Delivery

Eugene Polini, Technical Key Account Manager, Datwyler

  • Present the key considerations in selecting the appropriate parenteral packaging components.
  • Introduce solutions for manufacturing high-quality packaging components to meet the needs of the pharmaceutical industry.
  • Discuss risks that face the pharmaceutical industry today from a drug packaging perspective, and strategies to mitigate these risks.


The component selection process is a critical step in developing safe and effective primary packaging for pharmaceutical and biotech drugs. Considerations in component selection may involve evaluating a variety of elastomer compounds, assessing the need for additional protection through elastomer coatings, and establishing the best final seal, if applicable, to ensure the packaging maintains the drug product integrity.

10:45 AM - 11:35 AM

iSolve & Networking Break

11:35 AM - 12:10 PM - Case Studies

Biologics

QbD and Process Scale Up Considerations

  • Biological continuous manufacturing
  • Making sense of regulatory guidelines
  • Formulating drugs with manufacturing in mind

12:15 PM - 12:50 PM - Solution Spotlights

Small Molecules

Solution Spotlight Topic TBC (Foster Delivery Science)

Technology & Innovation

Solution Spotlight Topic TBC (Lonza)

12:50 PM - 1:50 PM

Networking Lunch

Lunch & Learn Round Table with MedPharm



Lunch & Learn Round Table with W.L. Gore

1:35 PM - 2:10 PM - Case Studies

Device Development

Considerations with the Development of Inhaled Combination Products

David Cipolla, VP of Research, Insmed Inc.

The development of any pharmaceutical product is a challenge, but the development and regulatory hurdles are even greater for an inhaled product.

Furthermore, most inhaled products are also combination products and that adds another layer of complexity, both from a technical, and a regulatory perspective, and thus there is increased risk of failure. This presentation will address the following:

  • What are the regulatory considerations for inhaled combination products?
  • What analytical tests are required for QC release and stability testing of inhaled combination products?
  • When can characterization studies be conducted during development to replace routine QC testing?

2:15 PM - 2:50 PM - Solution Spotlights

Device Development

Solution Spotlight Topic TBC (Sonceboz)

Small Molecules

Solution Spotlight Topic TBC (Cydex Pharmaceuticals)

2:50 PM - 3:40 PM

iSolve & Networking Break

3:40 PM - 4:55 PM - Case Studies

Small Molecules

Impact of Bile Salts on Solubilization and Membrane Transport of Supersaturated Drug Formulations

Helen Hao Hou, Senior Scientist Small Molecule Pharmaceutical Sciences , Genentech

Biologics

Mesoporous Silica Particles; Simple yet Powerful Tool for the Delivery of Biomolecules

Vivek Trivedi, Lecturer in Drug Delivery, Medway School of Pharmacy, University of Kent

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5:00 PM - 5:30 PM - Panel Discussion

Device Development

Preparing for Patient-Centric Drug Development Regulations

  • What do the recent FDA Guidelines on Patient-Focused Drug Development (PFDD) mean to us?
  • Why do we need more patient focussed thinking and design of drug products, medical devices and combination products? How will become more patient focussed shake up the industry and make us more competitive

5:30 PM - 5:35 PM

Chair’s Closing Remarks

8:00 AM - 8:45 AM

Registration

8:45 AM - 8:50 AM

Chair’s Opening Remarks

8:50 AM - 9:25 AM - Keynote

Technology & Innovation

Developing a QbD based Control Strategy for Continuous Manufacturing

  • Identifying QbD elements suitable for continuous manufacturing
  • Putting control strategies into practice for small and large molecule situations 

9:30 AM - 10:05 AM - Case Studies

Technology & Innovation

Challenges and Strategies in Formulation Development and Manufacture of High Concentration Biotherapeutics

Kevin Zen, Executive Director, Analytical Characterization, Formulation Development, and Biologics Manufacture, Anaptys bio

Subcutaneous (SC) injection of biotherapeutics has become a valuable alternative to intravenous administration across many disease areas. Most SC administration requires higher concentration of biotherapeutics. This poses unique challenges to drug delivery, formulation development, and manufacture in order to meet final product specifications and shelf life. Typically the high protein concentration challenges include solubility, opalescence, viscosity, particulate formation, protein aggregation and stability. In this talk, such challenges will be reviewed and addressed by real-world examples.

Small Molecules

Multivariate Analysis in the Pharmaceutical Industry

Mike Tobyn, Research Fellow, Bristol-Myers Squibb

  • Big data
  • Multivariate analysis
  • Validated techniques

10:10 AM - 10:45 AM - Solution Spotlights

Technology & Innovation

Solution Spotlight Topic TBC (Nanoform)

Device Development

Solution Spotlight Topic TBC (Sensile Medical)

10:45 AM - 11:35 AM

iSolve & Networking Break

11:35 AM - 12:10 PM - Case Studies

Technology & Innovation

Nanoparticles and Medicines Design

Ijeoma F. Uchegbu, Professor of Pharmaceutical Nanoscience , University College London

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Biologics

Challenges and Opportunities in Cell Therapy Formulation and Delivery

Bharathi Vellalore, Principal Scientist, Janssen

  • Formulation of autologous and allogeneic cell therapy products
  • Cold supply chain: Freezing, storage, transport, thawing and administration
  • Novel drug delivery approaches for solid tumor CAR-T therapy

12:15 PM - 12:50 PM - Solution Spotlights

Small Molecules

Solution Spotlight Topic TBC (Medincell)

Technology & Innovation

Solution Spotlight TBC: Agilent

Abstract TBC

12:50 PM - 1:50 PM

Networking Lunch

1:35 PM - 2:10 PM - Case Studies

Biologics

Device Development

How to use Smart Devices Intelligently to Deliver Outcomes

Jace Blackburn, Smart Device Engineer, Genentech

  • Introduction to Smart Devices
    • Types of Smart Devices & data they generate
    • Current Smart Device applications on the market
  • How to evaluate the fit of Smart Devices with a brand team’s digital strategy
    • Strategies to dig into with your marketing colleagues
    • Strategies that should raise red flags
  • How to execute a make vs buy decision for companion applications to support your digital strategy
  • Delivering on the prioritized outcomes through the implementation of behavior design
    • Intro on behavior design
    • Analyzing reasons for medication non-adherence or non-persistence with a behavior design lens

2:15 PM - 2:50 PM - Case Studies

Small Molecules

Fostering and Establishing a Culture of Innovation

  • Creating an environment that nurtures innovation
  • Innovation as part of your LCM strategy
  • Lessons to be learnt 

Technology & Innovation

Biodegradable Controlled Release Drug Delivery Systems

Controlled release systems PLA and PLGA systems
Avoiding lag times and high burst releases in controlled release systems

2:50 PM - 3:40 PM

Networking Break

3:40 PM - 4:55 PM - Case Studies

Technology & Innovation

Nanoparticles for targeted Tumour Drug Delivery

  • Improving stability of microparticle internalised chemotherapy
  • Potential to minimise systemic toxicity with new formulations

Biologics

Liquid Preformulation Assessment of Biological Candidates (1)

Shwetha Iyer, Senior Scientist- Formulation and Characterization , Novartis

  • Abstract TBC
     

5:00 PM - 5:30 PM - Panel Discussion

Device Development

What does the Future Hold for Novel Drug Delivery and Combination Products?

  • What are the current and anticipated hurdles to novel drug delivery?
  • What are the current biggest challenges to developing new combination products and how will this affect LCM?
  • How will new technology change current products (special focus on apps and connectivity)

5:30 PM - 5:35 PM

Poster Presentation Award

5:35 PM - 5:40 PM

Chair’s Closing Remarks